PHOENIX - A leading gynecologic surgery group reviewed adverse events about a controversial form of permanent birth control called Essure and published their findings.
The AAGL highlighted evidence of complications with the device, including high occurrences of ectopic pregnancies and allergic reactions to the device that cause pain. The organization represents more than 7,000 gynecologic professionals worldwide.
The ABC15 Investigators have been reporting on Essure for months, after dozens of women came forward to share their stories . Common complaints include bloating, rashes and chronic pelvic pain. Women also reported serious issues they say resulted from Essure, such as miscarriages and ectopic pregnancies.
Essure is marketed as permanent birth control without surgery. During the procedure, two metal coils are placed inside the fallopian tubes. Over the next three months, scar tissue is supposed to amass around the coils, blocking conception.
During their rally, the AAGL’s Executive Board agreed to meet with the women to talk about their experiences and their concerns about Essure.
Now, in their quarterly newsletter, the Medical Director of the AAGL, Dr. Franklin Loffer, analyzed 457 reported adverse events made to the Food and Drug Administration (FDA) about Essure.
He found pain was the most common symptom, and warned “pain that persists after the procedure should alert the physician to the possibility of complications.” That pain, Loffer wrote, could signal allergies to the nickel found in the Essure coils, a common complaint from women who spoke with ABC15.
Loffer recommended that patients who are screened for nickel hypersensitivity before getting the Essure device implanted could avoid common symptoms like nausea, rash and hives. Originally, when Essure was put on the market, women were advised to test for that allergy before getting the device implanted, but Bayer asked the FDA to remove that requirement a few years ago and the FDA complied.
Loffer also highlighted the “high occurrence” of ectopic pregnancies reported to the FDA. Twenty-nine of the 61 postoperative pregnancies were ectopic pregnancies, he wrote.
Last fall, Essure manufacturer Bayer Healthcare requested that the FDA allow them to change their patient information booklet to include side effects of the two most common complaints from women about the product, chronic pelvic pain and device migration. Many women reported that the metal coils can migrate out of the fallopian tubes after the device is implanted.
Bayer told the ABC15 Investigators they continuously review available information about their products, and "when appropriate…work collaboratively with the FDA to update the information available to patients and physicians."